SGLT2 Inhibition in Diabetes and Heart Failure

Completed

• Conditions: Heart Failure, Systolic; Diabetes Mellitus, Type 2

• Registration Number: NCT02862067
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.

Detailed Description

The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic heart failure.

Participants treated with SGLT2 inhibitor Empagliflozin as standard of care will undergo assessments described below.

The investigators will measure CRF with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether SGLT2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (VO2)(mL/kg/min) and minute ventilation (VE)/carbon dioxide production (VCO2) slope, powerful independent clinical predictors of mortality in HF.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-10
• Primary Completion: 2018-01-16
• Study Completion: 2018-01-16
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Confirmed clinical diagnosis of stable HF (NYHA class II-III) on maximally tolerated HF medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics
• Reduced left ventricular systolic function (LVEF<50%) documented in the prior 12 months
• Poorly controlled T2DM (HbA1c levels between 6.5% and 10.0%)
• 18 years old and older.

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Exclusion Criteria

• Type I diabetes;
• Type II diabetes with episodes of severe hypoglycemia <50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time);
• Open label treatment with SGLT2 inhibitors (within the past month);
• Treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention;
• Chronic Kidney Disease (GFR<45 ml/kg*min);
• Uncontrolled thyroid dysfunction (TSH<0.4>4.5 mcIU/ml);
• Pregnancy or of child-bearing potential;
• Active or recent (within 2 weeks) genital/urinal infection;
• Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart disease, angina, arterial hypotension (BP systolic <90 mmHg), orthostatic arterial hypotension, arterial hypertension (resting BP systolic >160 mmHg), atrial fibrillation with rapid ventricular response, severe valvular disease, severe chronic obstructive or restrictive pulmonary disease, moderate- severe anemia (Hgb<10 g/dl);
• Abnormal BP or heart rate response, angina or ECG changes (ischemia or arrhy- thmias) occurring during baseline cardio-pulmonary exercise testing;
• Chronic use of oral corticosteroids;
• Inability to give informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SGLT2 inhibition effects on cardiorespiratory fitness (CRF).	4 weeks	To measure the effects of Empagliflozin on cardiorespiratory fitness in patients with type 2 diabetes and heart failure with reduced ejection fraction or systolic heart failure. The effects on CRF are determined by measuring changes in peak VO2 (mL/kg/min) and the VE/VCO2 slope.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States